BEUDAMED
    FDA Recall Terminated

    Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be used in performing a quantitative, one -stage APTT. The citrate APTT test is used for evaluation of low doses of heparin anticoagulant (up to 1.5 units/mL), depending upon individual patient heparin sensitivity.

    Recall: Z-0937-2014 · Initiated December 19, 2013

    Recall

    Recall Number
    Z-0937-2014
    Event Number
    67237
    Firm
    ITC-Nexus Dx
    FEI Number
    2250033
    Product Code
    GFO
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 19, 2013
    Posted
    February 6, 2014
    Terminated
    October 30, 2014
    Address
    23 Nevsky St, Edison, NJ, 08820-2425

    Description

    Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be used in performing a quantitative, one -stage APTT. The citrate APTT test is used for evaluation of low doses of heparin anticoagulant (up to 1.5 units/mL), depending upon individual patient heparin sensitivity.

    Reason

    ITC has determined that some Citrate APTT cuvettes may recover higher than expected results in normal individuals.

    Action

    The firm, ITC The Point of Care, sent an "URGENT MEDICAL DEVICE RECALL" letter dated December 19, 2013 a long with an attached Health Professional Account Tracking Form via UPS to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to forward this communication to all those within your organization who need to be aware of this matter including any facility that you forwarded any of the affected product to; check all inventory to determine if you have any of the affected lots listed; if you have any affected lots, stop using them, remove from inventory and return to ITC; complete the attached Health Professional Account Tracking Form and return it within 10 days via fax to: 866-429-3132, email: [email protected] or mail to: ITC Technical Support, 20 Corporate Place South - Piscataway, NJ 08854 . It is important that you complete the form whether or not you have remaining inventory of these lots. In addition, contact ITC Technical Support immediately if you become aware of an unreported adverse event related to the use of affected J103C cuvettes. ITC will review your response form and will contact you to arrange for any inventory to be returned to ITC and ITC will replace all unused, returned product. If you have questions, please contact ITC Technical Support: Telephone 800-579-2255 or 732-548-5700, Extension 4011 or E-mail [email protected].

    Distribution

    Worldwide Distribution: US (nationwide) and countries of: Austria, Belgium, Canada, Serbia, Germany, Estonia, Italy, Spain and Saudia Arabia.

    Quantity

    25,965 curvettes (7,425 cuvettes US; 18,540 cuvettes OUS)